Category Archives: BCMA

CARTITUDE-1 and CARTITUDE-2 Study Updates; Carvykti Demonstrates Durable Responses at 2-Year Follow-Up; Legend Reports Delayed Cases of Parkinsonism; ASCO 2022 Legend Investor Event

On Sunday, June 5, Legend held their ASCO investor event highlighting updated clinical results from Carvykti’s (BCMA CAR-T; cilta-cel) Ph1b/2 CARTITUDE-1 and Ph2 CARTITUDE-2 studies in r/r MM. Below, Celltelligence provides insights on Carvykti’s durable responses in comparison with Abecma (BMS’s BCMA CAR-T), while discussing whether parkinsonism could require a novel mitigation strategy.

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Thoughts on Carvykti’s EC Conditional Marketing Authorization in ≥4L r/r MM

On Thursday, May 26, JNJ announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Carvykti (cilta-cel; BCMA CAR-T) in ≥4L r/r MM. Below, Celltelligence provides thoughts on Carvykti’s EC approval and its potential launch strategy within Europe.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Carvykti Meets Another Regulatory Milestone; LB1901’s FDA Clinical Hold Lifted; Legend Q1 2022 Earnings Summary

On Wednesday, June 1, Legend released their Q1 2022 results (press release) highlighting Carvykti’s (cilta-cel; BCMA CAR-T) recent European Commission (EC) conditional marketing authorization in ≥4L r/r MM. Additionally, management confirmed that the FDA lifted the clinical hold on LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on Carvykti’s EC approval, while discussing LB1901’s FDA clinical hold lift.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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The EC Grants Carvykti (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, May 26, JNJ announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Carvykti (cilta-cel; BCMA CAR-T) in ≥4L r/r MM. Of note, Carvykti’s EC approval was based on results from the Ph1b/2 CARTITUDE-1 trial. The Celltelligence team will be conducting a full thoughts-on analysis in the coming days.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gracell Q1 2022 Earnings Call

On Monday, May 16, Gracell held their Q1 2022 earnings call (press release / presentation).

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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TCR2 Tx, Poseida, 2seventy bio, and Cellectis Q1 2022 Earnings

A series of cell therapy-related news items were observed:

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Autolus to Evaluate MRD Status in Obe-cel’s FELIX Trial; First Patient Dosed in AUTO8’s MCARTY Study; Autolus Q1 2022 Earnings Call Summary

On Thursday, May 5, Autolus held their Q1 2022 earning call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) clinical progress, while confirming multiple clinical updates to be presented EHA 2022 (June 9 – 12). Of note, management confirmed the initiation of AUTO8’s (BCMA x CD19 CAR-T) Ph1 MCARTY trial in r/r MM. Below, Celltelligence provides insights on how Autolus may leverage MRD status to improve obe-cel’s efficacy and safety profile in r/r adult ALL, while discussing AUTO8’s trial initiation.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Breyanzi’s Sales Increase While Abecma’s Remain Flat; BMS Prepares for an Increase in Cell Therapy Demand; No Clinical Milestone Updates for Breyanzi or Abecma; BMS’s Q1 2022 Earnings Call Summary

On Friday, April 29, BMS held their Q1 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) revenue increase and anticipated US approval in 2L LBCL. Of note, no updated clinical milestones for Breyanzi and Abecma (BCMA CAR-T) were observed. Below, Celltelligence provides insights on how Breyanzi’s revenue increase compares with Kymriah (Novartis’s CD19 CAR-T) and Yescarta (Gilead/Kite’s CD19 CAR-T).

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Kymriah’s Sales Decline; PHE885 Pivotal Study Initiated; YTB323’s Anticipated Submission Delayed to 2025; Novartis’s Q1 2022 Earnings Call Summary

On Tuesday, April 26, 2022, Novartis held their Q1 2022 earnings call (press release / presentation) highlighting a decline in Kymriah’s (CD19 CAR-T) sales. Additionally, management noted Kymriah’s positive CHMP opinion in ≥3L FL, PHE885’s (T-Charge BCMA CAR-T) Ph2 trial initiation in 4L MM, and YTB323’s (T-Charge CD19 CAR-T) delayed regulatory filing in 2L DLBCL. Below, Celltelligence provides insights on Kymriah’s Q1 2022 revenue, while discussing YTB323’s delayed submission.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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